The FDA has issued a Marketing Denial Order (MDO) against the myblu Menthol 2.4% e-cigarette product of Fontem US, LLC (myblu), a subsidiary of Imperial Tobacco (ITG). The company will not be allowed to market or sell the product in the United States or face enforcement action from the FDA. The company may resubmit a new application to address the deficiencies associated with the marketing denial order.
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According to the U.S. Food and Drug Administration (FDA) website, the FDA has issued a Marketing Denial Order (MDO) against myblu Menthol 2.4% of Imperial Tobacco (ITG) subsidiary Fontem US, LLC (myblu). The company must not market or sell the product in the United States or face enforcement action from the FDA. The company may resubmit a new application to address the deficiencies associated with the marketing denial order.
On April 28, 2020, Fontem US LLC (Fontem US), a subsidiary of Imperial Tobacco, filed a premarket Tobacco Product Application (PMTA) with the FDA seeking authorization to continue marketing its various my blu e-cigarette products.
But in April 2022, The FDA also rejected the myblu device Kit and myblu Intense Tobacco Chill 2.5 percent, myblu Intense Tobacco Chill 4.0 percent, myblu Intense Tobacco 2.4 percent, and myblu Applications for products such as Intense Tobacco 3.6%, myblu Gold Leaf 1.2% and myblu Gold Leaf 2.4%.
This is the second time myblu has received a marketing denial order from the FDA since last year. Dr. Matthew Farrelly, director of the FDA’s Office of Tobacco Products (CTP) science, said:
“The application lacks scientific evidence that the positive public health effects of the product outweigh the known risks.”
The FDA evaluates pre-market Tobacco product applications (PMTA) based on public health criteria that consider the impact of the product on the population as a whole, including benefits (such as a complete transition to the product or appreciable reduction in combustible cigarette use among adult smokers) and risks (such as initiation of smoking among adolescents).
Tobacco products subject to an MDO may not be sold, distributed or marketed in the United States. In addition, such products may not enter or be transported into interstate commerce, and if the product is already on the market, it must be removed from the market or face FDA enforcement action.
To date, the FDA has received more than 26 million “product designation” applications and made decisions on 99 percent of them. The FDA has authorized the sale of 23 tobacco-flavored e-cigarette products and devices, which are currently the only e-cigarette products legally sold or distributed in the United States.
【1】FDA Denies Marketing of myblu Menthol E-Cigarette Product